Sedana Medical's AnaConDa approved to be used in children
Sedana Medical AB (publ) (SEDANA: FN Stockholm) today announced that the company's medical device AnaConDa, for the administration of volatile anesthetics for sedation of mechanically ventilated intensive care patients, has received approval for use on children by the European notifying body BSI Group. The approval also means that AnaConDa can be used in patients with severely impaired lung capacity.
"This means that we have no restrictions on the use of AnaConDa and that we can reach the entire market for mechanically ventilated intensive care patients. Regardless of whether you are a child, an adult or have reduced lung capacity." said Christer Ahlberg, CEO of Sedana Medical.
In February this year Sedana Medical received approval for its planned pediatric study by the Pediatric Committee of EMA, European Medicines Agency (PDCO). A complete application for the Marketing Authorization Application (MAA) in the EU for drugs must include an agreed and approved PDCO pediatric study plan, a so-called Pediatric Investigation Plan (PIP). The pediatric study thus ensures a complete application and thus ten years of market exclusivity in the EU.
"This approval for the use of AnaConDa in children is a prerequisite for us to be able to start our pediatric study in April 2020. It means that we have ticked off another important milestone." said Ahlberg.
For additional information, please contact:
Christer Ahlberg, CEO, Sedana Medical AB
Mobile: +46 70 675 33 30
Sedana Medical is listed on Nasdaq First North Growth Market in Stockholm.
The company's Certified Adviser is Erik Penser Bank, +46 8 463 83 00, firstname.lastname@example.org.
The information was released for public disclosure, through the agency of the contact person above, on September 30, 2019 at 10.00 a.m. (CET).
About Sedana Medical’s market
Sedana Medical's market consists primarily of sedation of mechanically ventilated intensive care patients. The market for sedation of mechanically ventilated intensive care patients today consists of established drugs that are administered intravenously. There are several challenges for both patients and care givers with today's intravenous treatment that are solved by inhaled sedation. Today, it is estimated that between seven and eight million patients are sedated due to mechanical ventilation in intensive care globally, evenly distributed between the US, Europe and Asia. These patients are sedated on average three to four days. Sedana Medical estimates the total market potential to SEK 20-30 billion.
Sedana Medical AB (publ) has developed and sells the medical device AnaConDa, for the administration of volatile anaesthetics to mechanically ventilated patients. A major clinical registration study is currently ongoing to obtain market approval in Europe for inhalation sedation in intensive care units with the pharmaceutical IsoConDa® (isoflurane).
Sedana Medical has direct sales in the Nordic countries, Germany, France, Great Britain and Spain as well as external distributors in the rest of Europe, Canada, Australia, Japan and South Korea. The company headquarters are based in Stockholm, Sweden with R&D operations in Ireland.